Is it really worth pushing for? Access to medicines in Europe today & the Joint Procurement Agreement proposed by the European Commission.
Policy recommendations & summary of views on the Joint Procurement Agreement (henceforth JPA) following talks with European Commission officials from multiple DGs and numerous health attaches of member states.
by Yannis Natsis (19/02/2015)
In April 2014, the European Commission approved a joint procurement agreement to be used against serious cross-border health threats by taking advantage of “any counter-measures”. It built on the difficulties that EU member states encountered in purchasing vaccines for the 2009 H1N1 pandemic. The goal of the Commission was to design a very flexible tool that can be employed against all communicable diseases. To this end, the EC’s legal services reiterate that the list of 40+ communicable diseases under surveillance by the European Centre for Disease Control (ECDC) in Stockholm is not restrictive. This list includes all of the usual kids’ diseases along with HIV, Hep C and TB among others. Cancer is excluded as it is not a communicable disease. In other words, the scope of application has been expanded well beyond the pandemic vaccines to include all counter-measures.
The first real use of the JPA is underway and it is about the purchasing of protective equipment for people taking care of Ebola and other diseases. The process has already been launched as 4 member states –which is the minimum number of states required to activate the procedure- have already expressed interest.
Participation in any JPA is voluntary. The Commission anticipates that most member states will be on board the JPA within the next semester. Nevertheless, even if all member states sign on to the JPA, this does not mean that they will ever use it. The Commission notes that Belgium is the driving force while France, Spain and Italy have always been supportive of such initiatives. Germany was cautious at first because of the Lander system but now is on board too. The UK does not want to use the JPA for pandemic vaccines; however it acknowledges its potential on the rest of the counter-measures. The case of Poland is quite interesting. They do not want to be part of the JPA at all as back in 2009; they never bought the vaccine against H1N1 and in retrospect and taking into account that in the end there was no real pandemic, that decision was a political victory for them. That is why, now no Polish politician wants to be seen favorable to an initiative that was not beneficial. Nevertheless, Commission officials emphasize the fact that Poland back in 2009 was simply lucky as had there been a real public health crisis, the country would have been left without vaccines. They comment that the JPA can be instrumental in guaranteeing the supply, the access as well as the best price especially for smaller member states.
As for the French initiative on Sovaldi, they comment that at the very beginning, it was not even clear whether Hepatitis C fell within the scope of a possible JPA but now the legal services have spoken and it does. In the opinion of people from DG SANTE that we have spoken to, Sovaldi was not the ideal example to use the JPA to start with as a) there are several national sensitivities and differences, b) countries had already started sharing information on a bilateral basis using managed entry contracts and c) there will be alternative treatments on the market shortly and hence competition will play its game. This is probably one of the reasons why none of the eight member states that have originally stated they would be interested in using the JPA on Sovaldi ever submitted a formal request to the EC.
The Commission strongly defends (or at least DG SANTE does) the JPA and notes that the Council has nothing to do with it; it is only between the Commission and the member states. It is keen to keep the Council out of it all together by saying that member states’ health attaches “bring politics where there is no politics at all”. They remind that the JPA is considered by the Commission and most member states (with the exception of Spain, France and Italy; they view it as an international treaty requiring parliamentary ratification) as a mere budgetary implementing measure of Decision 1082/2013 on serious cross border threats to health i.e. a simple agreement.
A JPA works in the following manner: the Commission is in the driving seat of the process. It is mandated by the member states involved with a clear set of terms of reference. A steering committee composed of Commission and member states representatives heads each JPA. Member states instruct the Commission, set the red lines and define the specifications as to how the tenders will be assessed. Specifications are public, but offers are not. Tenders are evaluated by the Commission with the help of “independent evaluators nominated by participating member states”. Evaluation reports can be requested by those who participated but they are not public as such. The award decision is public and contract can be made public at a later stage. A market is awarded on the basis of predefined award criteria; the weighing of technical and financial characteristics of the tender is one of them and “best value for money” will be awarded more points than the others. Needless to mention, that a JPA means that all member states involved get the same price, the same product and the same contract.
Most EU member states robustly oppose the JPA –along with some DGs in the Commission itself- as designed by the Commission for the following reasons: 1) the Commission has no competence over these issues, 2) this is a Trojan horse for the Commission to gain access to the area of medicines and to expand its mandate on the area of health in general, 3) they have serious reservations over the leading role of the Commission; to put it bluntly they do not trust it at all in conducting negotiations with pharmaceutical companies, 4) they support the view that there are no sufficient safeguards in place for the transparency and accountability, 5) they do not appreciate the fact that the Council is completely sidelined, 6) they believe that the Commission will act in obscurity and will be easily guided and manipulated by the pharmaceutical companies and 7) through JPAs pharma companies will enjoy a guaranteed volume and income. The fact that in the December 2014 Council Conclusions on Health, the original references to the JPA were removed from the final text is indicative of the mood in the Council against the JPA.
The Commission on the other hand is optimistic and committed to advocating for the JPA. It believes that it can be applied to medicines, for which several products exist on the market and have a marketing authorization. In their opinion, the high cost of new life-saving treatments and their impact on health systems’ sustainability will be a strong driver for the proliferation of future JPAs too.
Next steps
On the whole, the status quo is not conducive to promote the JPA as a main policy option to respond to the access to medicines problems in Europe today. Even so, several member states seem to encourage the option of pooled procurement through bilateral agreements. They view the centralized Commission-headed procedure with suspicion and caution but would be willing to examine the prospect of countries joining forces on an ad hoc basis. In principle, they agree that more countries united will lead to money-saving deals with pharmaceutical companies. The Commission replies that bilateral agreements are of course possible but comments that it will be difficult for the countries to define the terms of reference of such collaboration, whereas the JPA has all of the answers ready.
On our side, we can push for pooled procurement preferably through bilateral agreements as a way to achieve lower prices and weaken companies’ bargaining position. In all cases, our calls for joint purchases go hand in hand with a maximum degree of transparency and public scrutiny along with the need to buy medicines that have a proven added therapeutic value otherwise joint procurement can easily serve the pharmaceutical sector’s interests.